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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

A STUDY TO EVALUATE THE SAFETYAND CLINICAL EFFICACY OF JAUNDIF

NASAL DROPS (HERBAL PREPARATION)IN PATIENTS SUFFERING FROM JAUNDICE

AND VIRAL HEPATITIS

Shivani Chauhan1*, Sanjeev Jain1, Suman Singh1, Taru Jain1 and Bhagat Ram1

Research Paper

Aim: To evaluate the safety and efficacy of Jaundif nasal drops in patients suffering from jaundiceand viral hepatitis by multicentric case reports from upper northern parts of India. Methodology:A standard yellow form has been sent to 156 physician's practicing in the upper northern areasof India. Their feedback has been collected and subjected for analysis. The case reports oftreating different types of jaundice were pooled between the period of December 2004 to March2005 and has been subjected for analyses using inclusion as well as exclusion criteria. Results:After following inclusion and exclusion criteria, we collect 152 feedbacks of JAUNDIFF treatedpatients and analyzed 40 patients of viral hepatitis and 26 patients of jaundice, because resthave incomplete protocol sheet. Jaundif treated patients of jaundice and viral hepatitis showsextreme significant improvement in level of hepatic biomarkers (such as total serum bilirubin,conjugated bilirubin and SGPT) with mild side effects like, nausea, sore throat, and nasal irritationfor few moments. Conclusion: From results, we have concluded that this herbal transnasalpreparation (Jaundif) is effective for treatment of jaundice and viral hepatitis.

Keywords: Jaundif, Total serum bilirubin, SGPT level, Student T-test

*Corresponding Author: Shivani Chauhan � accuracy@akums.net

INTRODUCTION

Jaundice is one of the common symptoms of viral

hepatitis, hepatitis A, B, E (1) Drug induced

hepatitis which primarily appears due to

hyperbilirubinimea. (2) It is one of the diseases

still unconquered even in the West. There is no

specific therapy for jaundice and therefore a drug

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Int. J. Pharm. Med. & Bio. Sc. 2014

1 Akums Drugs & Pharmaceuticals Ltd., 301-305, Mohan Place, L S C Block-C, Saraswati Vihar, Delhi-110034, India.

which can minimize the clinical and biochemical

effects and restore the liver function quickly

without producing harmful effects is most

desirable. (3) But our indigenous system of

medicine ’Ayurveda’ offers some help. A number

of herbal medicines have claimed to be effective

in curing Jaundice in the old text books of Ayurveda

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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

but none of them gained access into the regular

therapeutic armamentarium of jaundice; and (4)

In quest of better treatment for jaundice we have

conducted a therapeutic trial of a drug ‘Jaundif

Herbal Nasal Drops’ (sponsored by AKUMS Drugs

and Pharmaceuticals Ltd.) which has been

claimed to cure jaundice miraculously. Jaundif is

not a single herbal medicine, but contains several

ingredients. The exact formulation and

composition can be obtained from the

manufacturer, Akums Drugs and Pharmaceuticals

Ltd., but the herbs used in jaundiff are of wild

varieties collected from higher altitude of Himalaya

which grow in specific soil and atmospheric

conditions. Jaundif differed in its mode of

administration from other herbal products as it

was given transnasally and in a single daily dose.

PATIENTS AND METHODS

A standard yellow form has been sent to 156

physician’s practicising in the upper northern

areas of India. Their feedback has been collected

and subjected for analysis. We collected 152

feedbacks of patients suffering from different type

of liver diseases as shown in Table 1.

In all the groups, diagnosis was based only on

clinical and biochemical findings. The protocol

sheet for every case denotes a detailed history

like duration of jaundice association with anorexia,

nausea/vomiting, itching and color of stool/urine.

Drug history contact with drug abusers, was also

recorded in detail. Routine examination of urine

and haematogram were done at the beginning

and after the last of treatment with Jaundif.

Blood sugar, serum bilirubin and SGPT levels

were estimated before starting the treatment.

Serum bilirubin levels and SGPT level were

estimated on the 4th, 8th and 15th day of treatment.

The statistical analysis was done by applying

paired students‘t’ test using Graph pad prism

software.

PATIENTS CHARACTERISTICS

Table 1: The Type and Number of Patientswith Elevated Liver Function Enzymes

Against Which The Jaundif Treatment Initiated

S. No. Diagnosis of Disease No. of Patients

1 Acute Hepatitis 1

2. Hepatitis (viral, A, B, & E) 90

3. Alcoholic liver disease 2

4. Drug induced hepatitis 1

5. Fatty liver disease 2

6. Jaundice (viral & obstructive) 54

7. Liver cirrhosis 2

Group A Group B

(Viral Hepatitis) (Jaundice)

No. of patients 40 26

Age Range 12-62 yrs 16-68 yrs

Males 29 20

Females 11 6

Baseline of total Bilirubin 10.15 8.27

Baseline of SGPT level 1312.33 581.04

RESULTS AND OBSERVATIONS

The study was carried out in 152 patients, but

due to incomplete information only 66 patients

were analyzed. They were divided into two groups

based only on clinical and biochemical findings.

1. Viral Hepatitis (including Hepatitis A, B and E,

and infective hepatitis)

2. Jaundice (viral jaundice, obstructive jaundice,

hemolytic jaundice).

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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

Effect of Jaundif on Total Serum Bilirubinin Viral Hepatitis Patients

Viral hepatitis group comprised of 40 Jaundif

treated patients. Upon nasal administration, the

liver function tests showed a significant

improvement from 4th day onwards. After the

treatment with Jaundif, total serum bilirubin levels

were significantly dropped from premedication

level 10.14 ± 0.95 mg/dl to 7.30 ± 0.69 mg/dl on

the 4th day; it was further reduced to 4.51 ± 0.54

mg/dl and 1.97 ± 0.25 mg/dl on 8th and 15th day

respectively with a range 3.2 to 27.1 mg/dl as

shown in Figure 1.

was a single blinded study, doctors knew the

treatment and give patients a single dose daily of

Jaundif for 15 days and checked the level of

Bilirubin total and SGPT at different intervals

(initially at pre medication level, after 4 days, after

8 days and after 15 days) as scheduled. During

the treatment period of 15 days some Physicians

permitted other drugs (such as B-complex,

Livonya syrup, Kumari Asava, Polybin syrup, and

liver tonic, etc.) as an adjunctive therapy. The

physicians were given some instructions

regarding bed rest, limited mobility and dietary

constrains like not to use oils, fats, tamarind,

chillies, spices, meat products and alcohol to

patients.

Effect of Jaundif on SGPT Level in ViralHepatitis Patients

The most important enzyme of liver, i.e., SGPT

is analyzed in Jaundif treated viral hepatitis

patients at beginning and 4th, 8th and 15th day of

the treatment. There is significantly decrease in

SGPT level was observed from day 8th of the

treatment when compared with pre-medication

level as shown in Figures 2 and 3. Jaundif

Figure 1: This Graph Represents Total SerumBilirubin Level in Jaundif Treated Patients

Note: Values are expressed as Mean ± SEM (n=40). *** indicates

extremely significant difference after treatment with jaundiff

when compared with pre-medication level (p<0.0001).

For Statistical analysis, only 26 patients of

jaundice, 40 patients of Hepatitis (including viral

hepatitis, hepatitis A, B, an d E), one patient of

drug induced hepatitis and one patient of fatty liver

disease are analyzed by using paired student T-

test. Both male and females (age range: 12 to

70) attending to different parts of India during the

period December 2004 to March 2005 are

included in the study. The patients and/or their

attendees were fully informed about the trial. This

Figure 2: This Graph Represents SGPT Level(U/L) in Jaundif Treated Viral Hepatitis Patients

Note: Values are expressed as Mean ± SEM (n=40). *** indicates

extremely significant difference after treatment with Jaundif

when compared with pre-medication level (p<0.0001),

whereas ns is no significant effect observed.

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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

attenuated the SGPT level from pre-medication

level (1312.33 ± 146.55) to 1016.9 ± 264.37 on

4th day. It further reduces to 197.85 ± 57.39 on

15th day with a range of 42 – 2700 U/L. Jaundif

reduces SGPT level upto normal in 30% of

individuals.

This Graph shows the mean percentage of

individual decrease in SGPT level at different time

period after the administration of transnasal

Jaundif drops.

Effect of Jaundif on Bilirubin Conjugatesin Viral Hepatitis Patients

The conjugate of Bilirubin is the most important

indicator of jaundice/viral hepatitis. It is also

analyzed in Jaundif treated patients initially and

after treatment at different time intervals (4th, 8th,

and 15th day). The percentage of conjugated

Bilirubin in JAUNDIFF treated patients of viral

hepatitis was decreased significantly from 4th day

onwards. It was observed that about 80% conj

bilirubin dropped down after 15 day of Jaundif

treatment when compared with premedication

level which is extremely significant result as

shown in Figure 4.

Adjunctive Therapy in Jaundif TreatedViral Hepatitis Patients

During the treatment period of 15 days, some

Physicians permitted other drugs (such as B-

complex, Livonya syrup, Kumari Asava, Polybin

syrup, and liver tonic, etc.) as an adjunctive

therapy (Figure 5). About 20% cases do not take

other medicines and treat disease significantly.

Figure 3: This Graph Shows the MeanPercentage of Individual Decrease in SGPT

Level at Different Time Period After theAdministration of Transnasal Jaundif Drops

Figure 4: This Graph Shows the MeanPercentage of Individual Decrease

in Conjugated Bilirubin Level at DifferentTime Period After the Administration of

Transnasal Jaundif Drops

Figure 5: Pie Chart Interprets theAdjunctive Therapy in Jaundif Treated

Viral Hepatitis Patients

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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

Observations during the clinicalevaluations are as follows:

None of the 40 patients complained of any

major side effects. However, allergy and untoward

effects; except slight throat burning and yellowish

nasal secretion for 12 to 24 h in some cases were

found which can be corrected by intake of

sufficient water after instillation Jaundif.

Effect of Jaundif on Total Serum Bilirubinin Patients of Jaundice

Jaundice group comprised of 26 Jaundif treated

patients. Upon nasal administration of herbal

Jaundif, the total serum bilirubin decreases

significantly from day 4 onwards with a range of

1.2 to 21 mg/dl. It reduces to 5.33 ± 0.84 mg/dl

from 8.27 ± 1.14 mg/dl in just 4 days and further

reduces to 3.40 ± 0.60 and 1.49 ± 0.44 mg/dl on

8th and 15th days respectively which is extremely

significant (P<0.0001) when compared with pre

medication level of total serum bilirubin at 95%

confidence level as shown in Figure 6.

Effect of Jaundif on SGPT Level (U/L) inPatients of Jaundice

Treatment with JAUNDIFF dropped the level of

SGPT in patients from premedication level.

Patients show variance in SGPT level from 17 to

3600 U/L. The mean average range of SGPT fall

down from pre medication 581.03 ± 235.59 to

355.93 ± 142.28 on 4th day of treatment with

JAUNDIFF, which is significantly (P<0.034).

Further the SGPT level dropped down to 44.71 ±

7.74 after 15 days of treatment which is very near

about normal level as seen in Figure 7. About

68.7% of patients come to their normal level of

SGPT after treatment with Jaundif for 15 days.

Figure 6: It Represents Total Serum BilirubinLevel (mg/dl) in Jaundiff Treated Patients

Note: Values are expressed as Mean ± SEM (n=26) *** indicates

extremely significant difference after treatment with Jaundif

when compared with pre-medication level (p<0.001).

Figure 7: This Graph Represents SGPT Level(U/L) in Jaundif Treated Jaundice Patients

Note: Values are expressed as mean ± SEM (n=26). * indicates

significant difference after treatment with Jaundif when

compared with pre-medication level at 95% confidence

interval.

Adjunctive Therapy in Jaundif TreatedPatients of Jaundice

About 31% cases of Jaundice didn’t take any other

medicine and showed significant improvement

with Jaundif. Also with addition of other

preparations, no other side effects were observed

(Figure 8).

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Int. J. Pharm. Med. & Bio. Sc. 2014 Shivani Chauhan et al., 2014

CONCLUSION

66 patients suffering from jaundice and viral

hepatitis with positive laboratory reports were

tested in an interventional clinical trial to assess

the clinical efficacy of transnasal herbal Jaundif.

Aqueous suspension of Jaundif was given

externally as a nasal drops into each nostril

followed by intake of sufficient water after

instillation with the direction of physicians. After

4th, 8th and 15th day of jaundiff treatment doctors

again evaluate the biochemical parameters of

patients and reported the results in yellow

feedback form. Then, we analyze and compare

Figure 8: Pie Chart Represents AdjunctiveTherapy in Jaundif Treated Patients

of Jaundice

the results of biochemical parameters at different

intervals from initial report by using paired student

t-test. From results, we have concluded that this

herbal transnasal preparation (Jaundif) is

significantly effective for treatment of jaundice and

viral hepatitis.

REFERENCES

1. Badgujar and Patil (2008), “Ethnomedicines

for Jaundice used in tribal areas of North

Maharashtra”, Natural Product Radiance,

Vol. 7, No. 1, pp. 79-81.

2. Click R, Dahl-Smith J, Fowler L, DuBose J,

Deneau-Saxton M and Herbert J (January

2013), “An osteopathic approach to

reduction of readmissions for neonatal

jaundice”, Osteopathic Family Physician,

Vol. 5, No. 1, p. 17.

3. Lidofsky S D (2010), Jaundice. In: Feldman

M, Friedman L S, Brandt L J (Eds.),

Sleisenger and Fordtran’s Gastrointestinal

and Liver Disease, 9th Edition, Philadelphia,

Pa: Saunders Elsevier; Chapter 20.